Trends for 2022: Brief provides focus for pharma

Master Control is offering “Top 4 Trends in Pharma for 2022,” a brief disseminated online. The publications says that there are four issues where top quality leaders in the pharmaceutical industry should stay focused to remain competitive. The brief also offers three ways to refine risk management tactics, information on why 70 percent of pharma companies are getting more value out of data than expected and input on how top companies are cutting deviation investigation times by 90 percent.

According to the brief, entitled, “The New Pharma Imperative: Quality Flexibility -- Pharmaceutical Quality Trend,” preserving the quality, safety and effectiveness of pharmaceutical products is extremely challenging now. “The wave of new complications arising from issues like supply chain disruptions, clinical trial setbacks and remote work inconveniences are no longer exceptions to the norm — they’re the new reality of doing business in the pharma sector. Quality professionals, in addition to carrying out their day-today tasks, are now responsible for adapting to and mastering change in an unsettled and rapidly evolving industry,” the brief explained.

Flexibility is critical, and quality experts can help their organizations to overcome the challenges presented by a world in disarray and guide companies into a new era of data and system connectivity. Informed quality leaders who stay aware of industry trends will be key drivers of transformation, versatility and success.

The first trend cited in the brief is the constant evolution of risk management expectations.  During the past decade, life sciences companies have seen a profound shift in regulatory agencies’ scrutiny of their risk management processes. Regulators keep increasing their emphasis on risk management and mitigation activities. “This pattern, in conjunction with the fallout from the COVID-19 pandemic, has intensified regulators’ appeals to pharma companies to adopt and/or bolster their risk-based approaches to quality compliance,” the brief said. Some pharma companies feel poorly prepared for these changes.

To stay competitive and versatile in the dynamic regulatory environment, pharma companies need to implement advanced digital tools to automate and streamline risk-related processes and appropriately link information across the enterprise. The brief recommends that they engage regulators early, update legacy systems and enhance analytics capabilities.

The second trend cited is “Success Hinges on Access to Good Data.” Because of the pandemic, there was an overall decrease in the number of FDA inspections conducted in 2020, but it was still a record year for the number of Form 483 Inspectional Observations the agency issued to pharma companies for inadequately controlling their digital systems and data, the brief said. The FDA has also started to reprimand clinical organizations for data integrity issues and ask for studies to be repeated. This, according to the brief, should not surprise anyone in the industry, given regulators’ continually increasing (and well-warranted) attention to data management matters in general. 

“Regulators are expected to continue to ramp up prioritization of data-related issues in the future, and trends indicate that digital manufacturing batch record and laboratory instrumentation data in particular are ongoing concerns,” the brief said. Reliable data enable pharma companies to drive continuous improvement and achieve truly intelligent quality management. When the data can be readily accessed and contextualized. 

“In order to achieve an environment where compliance is the de facto outcome, not the focus, organizations must establish the data fabric and create a data-centric culture where the ultimate value of data can be realized,” said Accenture Life Sciences R&D Operations Senior Manager Neil Fausz. “That means structuring and understanding your data and how you can use it to build predictable quality into the end-to-end process.”

To achieve data interoperability, the brief recommends that organizations make data their anchor. They should identify error-prone, repetitive processes. Finally, they need to establish structure with purpose-built tools.

The third major trend is the shift of AI from perk to survival-critical tool. According to the brief, “AI is venerated in the pharma world for its R&D applications and potential to revolutionize drug discovery, but the industry has only seen the tip of the iceberg in terms of what the emerging technology can do for quality. In recent case studies involving two companies’ use of machine learning (ML) for deviation resolution and critical process parameter range recommendations, AI-enabled systems helped them achieve a 70 percent reduction in deviation closure times and allowed them to identify root causes with 100 percent accuracy.

The last major trend is that optimized quality event management drives efficiency. Supervisors want everything identified immediately, to know who and what is affected by problems and to prioritize these problems, up-to-the-minute. The job is getting harder as the industry accelerates and more resilience is expected of the quality function. Quality professionals are overwhelmed by the mounting tasks of tracking all quality events throughout the enterprise in real time, understanding their impact on other functions and knowing if and when they should be escalated.

If establishing a culture of continuous improvement is an organizational goal, quality professionals need digital solutions to: 

• Visualize who is expected to interact with an event and when.

• Readily access data that can be directly incorporated into process and team improvements.

• Make changes to workflows and updates and/or corrections to forms promptly.

• Ensure the right data is captured at the right time and that it will be handled by the right people so they can make the right decisions.

“Pharma leaders that embrace innovative tools and adopt a risk-based approach to managing quality events will have greater capacity to identify and address quality problems quickly, which can dramatically accelerate overall quality and business performance,” the brief said.

The document concluded, “The leaders in the modern pharmaceutical industry are those who embrace and adapt to change. Those who cling to conventional, inflexible strategies and systems are struggling to survive, let alone compete. The key differentiator separating the pharma businesses that thrive from those that fail is their inclination to adopt a modern approach to quality management that incorporates proven, purpose-built technologies and prudent, forward-looking strategies for managing data and risk.”